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PD-L1/TGFbetaRII Inhibitor
M7824 in Patients With Metastatic Colorectal Cancer or With Advanced Solid Tumors With Microsatellite Instability
Phase 1 & 2
Waitlist Available
Led By Van K Morris, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new cancer immunotherapy to see if it can shrink tumors or help other treatments work better.
Eligible Conditions
- Rectal Cancer
- Colon Cancer
- Cancer
- Colorectal Cancer
- Lynch syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Circulating DNA Clearance
Secondary study objectives
Disease-Free Survival (DFS)
Grade 3 or Higher A/E Per CTCAE v4.03
Overall Survival (OS)
Side effects data
From 2023 Phase 1 & 2 trial • 4 Patients • NCT0343656375%
Rash
25%
Squamous Cell Ca of the Skin
25%
Actinic Keratosis
25%
Anorexia
25%
Diarrhea
25%
Fatigue
25%
Flu-Like Symptoms
25%
Mucositis
25%
Myalgia
25%
Hypothyroidism
25%
Condyloma
25%
Nasal Congestion
25%
Creatinine Kinase Increased
25%
Arthralgia
25%
Epistaxis
100%
80%
60%
40%
20%
0%
Study treatment Arm
IV Bintrafusp Alfa Every 14 Days at a Fixed Dose of 1200 mg
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (M7824)Experimental Treatment1 Intervention
Patients receive M7824 IV over 1 hour on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity (Cohorts A,B, and C) or for six doses in patients with detectable circulating tumor DNA (ctDNA) following resection of all known liver metastases (Cohort D).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anti-PD-L1/TGFbetaRII Fusion Protein M7824
2018
Completed Phase 2
~10
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,576 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,541 Total Patients Enrolled
Van K Morris, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Van K MorrisPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
1,530 Total Patients Enrolled